FDA Drugs recall ·
Fasenra (benralizumab) Injection, 30 mg/mL… recall
- Recall number
- D-0028-2026
- Date
- (initiated October 8, 2025)
- Company / brand
- Astrazeneca Pharmaceuticals
950 Wind River Ln, Gaithersburg, MD, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 916 pre-filled syringes
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30
Why was it recalled?
Lack of Assurance of Sterility:
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot YJ0152, Expiry: 01/31/2028.
Distribution
Nationwide in the U.S
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0028-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.